Surgical fasteners and fastening devices

ABSTRACT

The invention provides a surgical fastener. The fastener has a first element defining an axis of the fastener, and or more prongs attached to the first element at hinge regions. Deploying the fastener involves bending the prongs at the hinges so as to increase the distance of the prong tips from the axis and locking the fastener in this deployed configuration. The invention also provides a surgical fastening device and a method for attaching a surgical fastener to a site of a body tissue.

FIELD OF THE INVENTION

This invention relates to surgical fasteners and to surgical fasteningdevices.

BACKGROUND OF THE INVENTION

Surgical anchors are used instead of surgical suturing, which is oftenboth time consuming and inconvenient, in order to join two tissuelocations. A surgeon can often use a stapling apparatus to implant ananchor into a body tissue and thus accomplish in a few seconds, whatwould take a much longer time to suture. A surgical anchor is used, forexample in inguinal hernia surgery to fasten polypropylene mesh to theabdominal wall in order to reinforce the abdominal wall.

Conventional surgical fasteners have been in the form of ordinary metalstaples, which are bent by the delivery apparatus to join together bodytissues. These staples comprise a pair of legs or prongs joined togetherat one end by a crown that may be straight or arcuate. During deploymentof the staple, the prongs are inserted into a tissue and are then madeto bend inwards towards.

At present, there are a variety of surgical fasteners and fasteningdevices available for endoscopic or open procedures, to attach tissuestogether, or to attach a mesh patch to a tissue. One such surgicalfastener is a surgical stapler, or clip applicator. In this stapler, aplurality or stack of unformed staples are contained within a cartridgeand are sequentially advanced or fed within the instrument by a springmechanism. A secondary feeding mechanism is employed to separate thedistal most staple from the stack, and to feed the distal most staplerinto the staple closing mechanism. Such mechanisms are found in U.S.Pat. Nos. 5,470,010, and 5,582,616.

In some applications, the body tissue is accessible from two oppositedirection so that an anvil may be used to deform the legs of a stapleafter having passed through the body tissue. In applications whereaccess to the tissue is from only one direction, an anvil may be used todeform the crown of a conventional staple so that the legs projecttowards each other in the body tissue so as to hold the staple in thetissue.

Another stapler mechanism, used mostly for mesh attachment to tissuedoes not use an anvil. Instead, a fastener comprising a helical wire isscrewed or rotated into a tissue, in order to join tissues to affix apolypropylene or similar material mesh or other patch to the tissuetogether. Instruments and fasteners of this type are found in U.S. Pat.Nos. 5,582,616, U.S. 5,810,882, and U.S. 5,830,221. Another type offastener that does not need an anvil applies fasteners made from a shapememory alloy such as Nitinol™. These fasteners are mainly used to fastenprosthetic material or artificial mesh to tissue.

These fasteners and fastening devices suffer from significant drawbacksespecially when attaching fasteners to soft tissue. The strength ofattachment of these devices depends mainly on the content and size ofcollagen fibers. Most soft tissue, such as subcutaneous tissue and fattytissue surrounding internal organs, has few and slender collagen fibersand hence the attachment of the common art fasteners to such tissue isweaker than attachment to stronger tissues such as fascia or ligaments,which have more and larger collagen fibers.

There is a need for a fastener that permits a stronger attachment tosuch soft tissue by attaching to a large surface.

There is a need for a fastener that has a narrow profile beforedeployment and increases to a large radius in the deployed state byextension of radial prongs for grasping the soft tissue.

There is a need for a fastener in which the extension of the prongs isperformed by applying forces within the fastening instrument only andnot by forcing the device against the tissue, by penetrating the tissue,or by pulling the device through tissue, actions which may causeinadvertent injury to tissue and improper attachment.

There is a need for a fastener that can attach a graft or mesh to suchsoft tissues.

There is a need for a fastener that can retain its deployedconfiguration despite forces that tend to detach it, preferably byproviding locking means within the fastener.

There is a need for a fastening device that can deploy one or a stack ofsuch fasteners.

There is a need for a fastening device, which can deploy a fastener byapplying forces only within the fastening device without the need toapply forces on the tissue.

There is a need for a fastening device, in which the deployment andrelease of the fastener are performed by separate means.

There is a need for a fastening device that can grasp a mesh or a graft,bring it to the desired location and attach it to soft tissue bydeploying a fastener.

SUMMARY OF THE INVENTION

In its first aspect the invention provides a surgical fastener. Thesurgical fastener of the invention comprises two or more prongs each ofwhich is connected to a first element by a hinge. The fastener ispositioned at the site of a tissue surface where it is to be deployed.The fastener is then deployed by applying an extending force to theprongs so that the prongs splay radially outward from the first elementby rotating at the hinges as they enter the body tissue so as to becomeembedded in the tissue. The fastener may be used to attach a graft or amesh to a body tissue. In contrast to the prior art surgical anchorswhich penetrate the tissue entirely, in the case of the surgicalfastener of the present invention, only the prongs of the fastenerpenetrate through the graft or mesh into the tissue, while the firstelement to which the prongs are connected attach the graft or mesh tothe tissue surface without penetrating into it.

The first element or crown, may have any shape, as required in anyapplication. For example, the first element may have a shape such as aflat disk, a rectangular or polygonal shaped flat surface, anirregularly shaped flat surface, an annular ring, a cylindrical ring, ora cylinder.

The fastener may contain any number of prongs that is at least two. Theprongs may have any profile as required in any application, such as arectangular profile, a round profile, an oval profile, a triangularprofile, or an elliptical profile. The prongs may be straight or curvedwith constant or variable curvature. The prongs may be manufacturedintegrally with the first element. In this case an integral hinge isformed at the attachment site of each prong to the first element. Theintegral hinge may be formed, for example, as a region of decreasedthickness or width of the prong, or by a perforation in the prong. Theprongs may be manufactured separately from the first element and thenattached to the first element, for example, using an adhesive.Alternatively, the prongs may be attached to the first element by atwo-part hinge, for example, a two-part hinge formed by hooking theprongs onto the first element. The prongs may have blunt tips, pointedtips or barbed tips, as required in any application.

In some embodiments, the fastener includes a second element orbaseplate. In these embodiments, the prong tips are inserted into slotsin the second element.

In an undeployed configuration the prongs tips are engaged within theslots in the second element or protrude minimally beyond the secondelement plane and the prongs are held in this position due to anengagement between the prongs and the second element, for example, byfriction between the prongs and slot edges or by adhesive, glue or by aplug of softer material such as a biodegradable material. A fasteningdevice is deployed by urging the first element towards the base. As theprongs pass through the slots, the force applied to the prongs by theslot edges causes them to rotate at the hinge and splay radially outwardfrom the crown. The second element may have any shape, as required inany application. For example, the second element may be a baseplatehaving a shape such as a flat disk, a rectangular or polygonal shapedflat surface, an irregularly shaped flat surface, an annular ring, acylindrical ring, or a cylinder.

The fastener of the invention may be manufactured from stainless steel,Nitinol, titanium or other biocompatible metallic alloys. It may bemanufactured from biocompatible, and possibly biodegradable, plastic ormetallic materials or a combination of such materials.

The fastener of the invention is locked in the deployed configuration inorder to prevent unintended release of the fastener from the bodytissue. As used herein, the term “locking” of the fastener refers to anengagement between components of the fastener that increases the forcenecessary to bend the extended prongs of the deployed fastener closer tothe longitudinal axis of the fastener compared to situation in whichsuch means are not provided. The result is that the fastener retains itsdeployed configuration despite the forces that act on it within thetissue and is better attached to the delicate soft tissue.

The locking may be due to an engagement between the prongs and the firstelement. If a second element is present in the fastener, the locking maybe due to an engagement between the second element and the prongs or thesecond element and the first element. For example, the locking mayresult from increased friction between the prongs and slots due to aregion along the length of the prongs of increased width or thicknessthat enters the slot during deployment, so that the prong becomes jammedin the slot. The prongs may be locked in the deployed configuration byengagement of a tongue extending from each slot of the second elementinto an opening in the prong. Alternatively, a tongue in the prong mayengage an opening in the second element.

In its second aspect the invention provides a surgical fastening devicefor deploying a surgical fastener. The fastening device of the inventionis configured to receive one or more fasteners to be deployed in a bodytissue. The device is configured to apply an extending force to theprongs of the fastener to cause the prongs to splay radially outwardfrom the first element by rotating at the hinges. The fastening devicemay have, for example, a slender hollow shaft containing a stack of oneor more fasteners. In this case, the tip of the shaft is delivered tothe body site where the fastener is to be deployed. As the fastener isbrought to its deployed configuration by the fastening device, theprongs splay out from the first element into the body tissue at thatsite. Once the fastener has attained its deployed configuration, thefastener is released from the fastening device. The fastening device ofthe invention is preferably manufactured from biocompatible materials,such as biocompatible metallic or plastic materials, or a combination ofthem.

The surgical fastening device of the invention may have a slender shaftconfigured to receive a stack of surgical fasteners of the invention. Aplunger inside the shaft is activated to deliver a force to the stack offasteners that is transmitted to the fastener at the shaft tip. Theshaft tip is configured to apply a counter force to this fastener sothat the prongs of the fastener experience an extending moment to theprongs that brings the fastener into its deployed configuration. Afterdeployment of the fastener, a releasing mechanism releases the deployedfastener from the fastening device. The shaft may be rigid, semi-rigidor flexible. It may be flexible along its entire length or only atspecific locations thus permitting manipulation of the shaft in narrowbody spaces.

In some embodiments, a surgical filament may pass through the fastenersor around the fasteners and may be grasped by the fastener when thefastener is deployed in a tissue. This filament may be used to bridgetwo or more fasteners attached to different tissues sites, for example,in order to approximate the different tissue sites. The filament may bea thread with any profile, a sheet of plastic material, or a net or meshof plastic or metallic material. A sheet, net, or mesh may be used byenveloping it as a sleeve around the shaft of a fastening device. Inthis case, when a fastener is deployed at the shaft tip, the prongspierce the sleeve from inside through the filament and then penetratethe tissue, thus fixing the sleeve to the tissue.

The term “deploying the fastener” means extending the prongs to theirfull extent in relation to the first element or the crown.

The term “releasing the fastener” means disengaging the fastening devicefrom the deployed fastener.

Thus, in its first aspect, the present invention provides a surgicalfastener having an undeployed configuration and a deployedconfiguration, comprising:

-   -   (a) a first element defining an axis of the fastener; and    -   (b) two or more prongs, each prong being attached to the first        element at a hinge and each prong having a tip;        wherein, in the undeployed configuration, the tip of each prong        is at a first distance from the axis that is greater than a        distance of the prong's hinge from the axis; and wherein, in the        deployed configuration, the tip of each prong is at a second        distance from the axis that is greater than the first distance        and wherein the fastener is locked in the deployed        configuration.

In its second aspect, the invention provides a surgical fastening devicefor deploying one or more surgical fasteners, each surgical fastenerhaving an undeployed configuration and a deployed configuration, andcomprising:

-   -   (a) a first element defining an axis of the fastener; and    -   (b) two or more prongs, each prong being attached to the first        element at a hinge and each prong having a tip;        wherein, in the undeployed configuration, the tip of each prong        is at a first distance from the axis that is greater than a        distance of the prong's hinge from the axis; and wherein, in the        deployed configuration, the tip of each prong is at a second        distance from the axis that is greater than the first distance;        the surgical fastening device comprising:    -   a. a receptacle adapted to receive one or more surgical        fasteners in the undeployed configuration, and    -   b. a deployment mechanism configured to bring a fastener in the        receptacle to its deployed configuration by applying a first        force to first element and a second force to the prongs wherein        the second force is directed in a direction essentially opposite        to the direction of the first force.

In its third aspect, the invention provides a surgical fastening systemcomprising:

-   -   (a) a surgical fastening device for deploying one or more        surgical fasteners, each surgical fastener having an undeployed        configuration and a deployed configuration, and comprising:        -   (i) a first element defining an axis of the fastener; and        -   (ii) two or more prongs, each prong being attached to the            first element at a hinge and each prong having a tip;            wherein, in the undeployed configuration, the tip of each            prong is at a first distance from the axis that is greater            than a distance of the prong's hinge from the axis; and            wherein, in the deployed configuration, the tip of each            prong is at a second distance from the axis that is greater            than the first distance;            the surgical fastening device comprising:    -   a receptacle adapted to receive one or more surgical fasteners        in the undeployed configuration,    -   a deployment mechanism configured to bring a fastener in the        receptacle to its deployed configuration by applying a first        force to first element and a second force to the prongs wherein        the second force is directed in a direction essentially opposite        to the direction of the first force; and    -   a releasing mechanism for disengaging the fastening device from        the fully deployed fastener; and    -   (b) one or more surgical fasteners, each of the one or more        surgical fasteners comprising:        -   (iii) a first element defining an axis of the fastener; and        -   (iv) two or more prongs, each prong being attached to the            first element at a hinge and each prong having a tip;            wherein, in the undeployed configuration, the tip of each            prong is at a first distance from the axis that is greater            than a distance of the prong's hinge from the axis; and            wherein, in the deployed configuration, the tip of each            prong is at a second distance from the axis that is greater            than the first distance.

In its fourth aspect, the invention provides a method for attaching asurgical fastener to a site of a body tissue, the surgical fastenercomprising

-   -   (a) a first element defining an axis of the fastener; and    -   (b) two or more prongs, each prong being attached to the first        element at a hinge and each prong having a tip;        wherein, in the undeployed configuration, the tip of each prong        is at a first distance from the axis that is greater than a        distance of the prong's hinge from the axis; and wherein, in the        deployed configuration, the tip of each prong is at a second        distance from the axis that is greater than the first distance;        the method comprising applying an extending force to the prongs        to fully deploy the fastener by forces exercised within the        fastening instrument, wherein the extending prongs pierce a mesh        or a graft and the adjacent tissue and the first element of the        fastener attach said mesh or graft to the tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, preferred embodiments will now be described, by way ofnon-limiting example only, with reference to the accompanying drawings,in which:

FIG. 1 shows a surgical fastener in an undeployed configurationaccording to one embodiment of the invention;

FIG. 2 shows the surgical fastener of FIG. 1 deployed in a tissue;

FIG. 3 shows a surgical fastener in an undeployed configurationaccording to another embodiment of the invention;

FIG. 4 shows the surgical fastener of FIG. 3 in a deployedconfiguration;

FIG. 5 shows a surgical fastener in an undeployed configurationaccording to another embodiment of the invention;

FIG. 6 shows a surgical fastener having a hollow lumen in an undeployedconfiguration according to another embodiment of the invention;

FIG. 7 shows a surgical fastener in a deployed configuration grasping asurgical filament according to another embodiment of the invention;

FIG. 8 shows a surgical fastener in an undeployed configurationaccording to another embodiment of the invention;

FIG. 9 shows a surgical fastener having a two-part hinge in anundeployed configuration;

FIG. 10 shows the surgical fastener of FIG. 9 in a deployedconfiguration;

FIG. 11 shows a surgical fastener according to yet another embodiment ofthe invention;

FIG. 12 shows the surgical fastener of FIG. 11 in a deployedconfiguration in which the fastener is locked by an engagement betweenthe first and second elements;

FIG. 13 shows a surgical fastener according to yet another embodiment ofthe invention;

FIG. 14 shows the surgical fastener of FIG. 13 in a deployedconfiguration in which the fastener is locked by an engagement betweenthe prongs and the first element;

FIG. 15 shows a surgical fastener according to an embodiment of theinvention in which the first and second elements are coaxial cylinders;

FIGS. 16a-16b shows a surgical fastener according to another embodimentof the invention in which the first and second elements are coaxialcylinders and the second element is provided with prongs;

FIG. 17 shows a surgical fastener in an undeployed configurationaccording to another embodiment of the invention in which the firstelement is a disk that rotates relative to the second element;

FIG. 18 shows the surgical fastener of FIG. 17 in a deployedconfiguration;

FIG. 19 shows a surgical fastening in a perspective view device inaccordance with embodiment of the invention;

FIGS. 20a-20c shows the surgical fastening device of FIG. 19 in alongitudinal sectional view during deployment of a surgical fastener;

FIGS. 21a-21b shows a surgical fastening device in accordance withanother embodiment of the invention;

FIG. 22 shows a surgical fastening device in accordance with anotherembodiment of the invention;

FIG. 23 shows the surgical fastening device of FIG. 22 in a longitudinalsectional view;

FIG. 24 shows a surgical fastening device having a curved shaft prior todeployment of a surgical fastener in accordance with another embodimentof the invention;

FIG. 25 shows the surgical fastening device of FIG. 24 during deploymentof a surgical fastener;

FIGS. 26a-26b shows the surgical fastening device of FIGS. 24 and 25 ina perspective view (FIG. 26a ) and an enlargement of the distal end(FIG. 26b );

FIG. 27 shows a surgical fastening device in accordance with anotherembodiment of the invention attached to a handle at a hinge;

FIG. 28 shows a surgical fastening device having protrusions at itsdistal end for grasping a surgical mesh in accordance with anotherembodiment of the invention;

FIGS. 29a-29c shows the distal end of a surgical fastening device of theinvention configured to deploy a surgical fastener not having a secondelement;

FIG. 30 shows the distal end of a surgical fastening device of theinvention configured to deploy a surgical fastener not having a secondelement, in accordance with another embodiment of the invention;

FIG. 31 shows the distal end of a surgical fastening device of theinvention configured to deploy a surgical fastener together with asurgical filament;

FIG. 32 shows a stack of surgical fasteners of the invention;

FIG. 33 shows the distal end of a surgical fastening device of theinvention configured to deploy the surgical fasteners of FIG. 32;

FIGS. 34a-34e shows the mechanism of a surgical fastening device duringdeployment of a surgical fastener according to yet another embodiment ofthe invention;

FIG. 35 shows a surgical fastening device having a surgical filamentdelivery system in accordance with another embodiment of the invention;

FIG. 36 shows the distal end of a surgical fastening device according toanother embodiment of the invention;

FIG. 37 shows the distal end of a surgical fastening device according toanother embodiment of the invention in which surgical fasteners movetowards the distal end under the influence of a spring;

FIG. 38 shows deployment of a surgical fastener by the surgicalfastening device of FIGS. 37 and 38;

FIG. 39 shows the distal end of a surgical fastening device according toanother embodiment of the invention having a ratchet mechanism formoving surgical fasteners in a distal direction while preventingmovement of surgical filaments in a proximal direction; and

FIG. 40 shows a surgical fastener for use with the surgical fasteningdevice of FIGS. 36, 37, 38, and 39.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1 and 2 show a fastener 1 in accordance with one embodiment of thefastener of the invention. The fastener 1 is shown in FIG. 1 in itsundeployed configuration from a side perspective view. The fastener 1 isshown in FIG. 2 in its deployed configuration in a tissue 21 from a sideperspective view. The tissue 21 is indicated by broken lines in FIG. 2.The fastener 1 has a first element in the form of a flat crown 11. Thefastener 1 also has a second element in the form of a flat baseplate 12.Two or more prongs 13 extend from the crown 11 at hinge regions 16. Eachhinge region 16 is a weakened region at the attachment site of eachprong 13 to the crown 11. The integral hinge 16 between the crown 11 andprongs 13 may be formed by attachment of the prongs to the crown withbiocompatible glue or adhesive that is weaker than the material of thecrown and prongs. In this embodiment, the crown 11 is integrally formedwith the prongs 13. Eight prongs 13 are shown in FIG. 1, but this is byway of example only and the fastener 1 may have any number of prongs 13that is greater than or equal to 2. Each prong 13 terminates in a tip14. The baseplate 12 has a number of slots 15 through which the tips 14of the prongs 13 pass in the assembled fastener 1 in the undeployedconformation (FIG. 1).

In order to mount the crown 11 on the base 12, the prongs 13 are bent atthe hinge regions 16 in order to bring the prongs close to an axis 19 ofthe fastener 1. In this configuration, the tips 14 are inserted intoslots 15 in the baseplate 12, as shown in FIG. 1.

The fastener 1 is applied to the surface of a body tissue and deployed.Deploying the fastener 1 involves moving the crown 11 relative to thebaseplate 12 along the axis 19 so as to decrease the separation of thecrown 11 and the baseplate 12. This is accomplished by applying a normalforce on the crown 11 directed towards the baseplate 12 as indicated bythe arrow 20 a and a counterforce on the baseplate 12 in the oppositedirection indicated by the arrow 20 b. These forces urge the crown 11toward the baseplate 12. As the crown 11 approaches the baseplate 12,the prongs 13 experience an extending movement by the edges of the slots15 that causes the prongs 13 to rotate at the hinge region 16 and movein a radially outward direction from the crown 11 penetrating the bodytissue 21, while the crown 11 and baseplate 12 remain at the surface.This extending of the prongs at the hinge region is due to the fact thatthe hinge regions 16 are weaker than the rest of the prongs 13 and thatthe moment acting in the prong during deployment is maximal at thehinge. A a weaker hinge region lowers the force required within afastening device to extend the prongs during deployment. This forcedepends on the resistance of the hinges to the extending moment. Weakhinge means low resistance. As the crown 11 moves toward the base 12,the prongs 13 advance through the slots 15. The hinge regions 16 arelocated at a distance from the center of the crown 11 that is less thanthe distance between the slots 15 and the center of the baseplate 12.Thus, as the prongs 13 pass through the slots 15, the prongs tips movethrough a curved trajectory and the prongs 13 splay outward from thebaseplate 12 in the deployed configuration shown in FIG. 2. Duringdeployment of this embodiment there is no deformation of the crown 11,the prongs 13 or the baseplate 12.

A hole 17 in the crown 11 and a hole 18 in the baseplate may be providedfor permitting the passage of a filament through the fastener 1. Theholes 17 and 18 may be coaxial, or may not be coaxial, as shown inFIG. 1. The filament may be grasped between the baseplate of thedeployed fastener and the tissue surface.

When the holes 17 and 18 are not coaxial the filament may also begrasped between the crown 11 and the baseplate 12.

Only the integral hinge 16 undergoes plastic deformation. This plasticdeformation of the hinge 16 maintains the fastener 1 in its deployedconfiguration. When a pulling force is applied to the baseplate 12 ofthe fastener 1 attached to a body tissue 21, for example, by puling on amesh, or graft, which is attached by the fastener 1 to the tissue, themaximal moment in each prong is at the line of contact along the prongwhere the prong passes through the slot, and not at the weaker hinge.Therefore, the force needed to bend the prongs in order to remove thefastener from the tissue is greater than the force that would have beenrequired to bend the prongs at the hinges if the baseplate were notpresent. Thus, with the baseplate, the fastener is capable ofwithstanding forces acting on the baseplate tending to pull the fastenerout of the tissue.

FIGS. 3 and 4 show a fastener 100 in accordance with another embodimentof the fastener of the invention. The fastener 100 is shown in FIG. 3 inits undeployed configuration from a side perspective view. The fastener100 is shown in FIG. 4 in its deployed configuration from a bottomperspective view. The fastener 100 has a first element in the form of aflat crown 101. The fastener 100 also has a second element in the formof a flat baseplate 102. Two or more prongs 103 extend from the crown101 at hinge regions 109. The baseplate 102 has a number of slots 115through which the prongs 103 pass.

A hole 107 is provided in the baseplate 102 with a flap 104 that isinitially bent out of the plane of the baseplate 102 in the undeployedconfiguration. A surgical filament 105 is shown passing through the hole106 of the crown 101 and the hole 107 in the undeployed fastener. Duringdeployment, as the crown 101 approaches the baseplate 102 the flap 104is bent by the crown into the plane of the baseplate 102 and thus firmlygrasps the filament (FIG. 4). The prongs 103 are locked in the deployedconfiguration by engagement of a tongue 108 extending from the baseplate102 into each slot, 115 into an opening 119 in each prong 103.

FIG. 5 shows a fastener 160 in its undeployed configuration inaccordance with another embodiment of the fastener of the invention. Thefastener 160 is shown in FIG. 5 in its undeployed configuration from aside perspective view. The fastener 160 has a first element in the formof a flat annular crown 161. The fastener 160 also has a second elementin the form of a flat annular baseplate 165. Prongs 164 extend from thecrown 161 at hinge regions 162. The hinges 162 are integral hingesformed by a thinned region 163 of each prong 164 at the site ofconnection to the crown 161. The baseplate 165 has slots 167 throughwhich the prongs extend.

FIG. 6 shows a fastener 170 in its undeployed configuration inaccordance with another embodiment of the fastener of the invention. Thefastener 170 is shown in FIG. 6 in its undeployed configuration from aside perspective view. The fastener 170 has a first element in the formof a cylindrical crown 171. The fastener 170 also has a second elementin the form of a cylindrical baseplate 175.

Prongs 174 extend from the crown 171 at hinge regions 172. The baseplate175 has slots 177 through which the prongs extend. The fastener 170 hasa hollow lumen 176, and is thus adapted for deployment in a body lumensuch as a blood vessel.

FIG. 7 shows a fastener 700 in its deployed configuration in accordancewith another embodiment of the fastener of the invention. The fastener700 is shown in FIG. 7 from a top perspective view. The fastener 700 hasa first element in the form of a flat crown 711. The fastener 700 alsohas a second element in the form of a baseplate 710. Prongs 715 extendfrom the crown 711 at hinge regions 713 formed by a narrowed region atthe connection of each prong 715 to the crown 711. A surgical filament712 is shown in FIG. 7 grasped between the crown 711 and the baseplate710 in the deployed fastener. The filament 712 may serve to remove thefastener from the tissue at any time after deployment. The fastener 700is brought to its undeployed configuration by immobilizing the baseplateand pulling the filament 712 so as to pull the crown 711 away from thebaseplate.

FIG. 8 shows a surgical fastener 70 in its undeployed configuration, inaccordance with another embodiment of the invention. The fastener 70 hasS shaped prongs 73 that are joined together at a common attachment site76 that forms a crown 76. The fastener 70 does not have a baseplate. Thefastener 70 is deployed by applying a normal force on the crown 76directed towards the prong tips as indicated by the arrow 74 a and acounterforce on the prong tips 75 in the opposite direction indicated bythe arrow 74 b. These forces generate an extending force on the prongs73 that causes the prongs 73 to rotate at the hinge region 76 and movein a radially outward direction from the crown 76 to penetrate the bodytissue, while the crown 76 remains at the surface.

FIGS. 9 and 10 show a fastener 80 in accordance with another embodimentof the invention. The fastener 80 is shown in FIG. 9 in its undeployedconfiguration from a side perspective view. The fastener 80 is shown inFIG. 10 in its deployed configuration from a side perspective view. Thefastener 80 has a first element in the form of a flat crown 81 fromwhich extend prongs, and a second element in the form of a flatbaseplate 82. Each prong 83 is joined to the crown by a hinge 86 that isnot formed integrally with the crown. The hinge 86 is a two-part hingeformed by a hook 87 formed near the end of each prong that is engaged ina slot 88 in the crown. Urging the crown 81 towards the baseplate 82causes the prongs 83 to rotate at the hinge region 86 as the prongsadvance through slots 85 in the baseplate 82 and the fastener achievesits deployed configuration with the prongs extending radially outwardsas shown in FIG. 10. The fastener is locked in the deployedconfiguration due to jamming of a widened portion 89 of the prongs 83near the crown 81 in the slots 85.

The length of the prongs of the fastener of the invention may vary. Theshape of the prongs may be straight, for example, as shown in FIG. 3.The prongs may be curved with uniform curvature as shown in FIG. 1, ormay have a variable radius of curvature as shown in FIG. 8. The profileof the prong may be round, elliptic, rectangular, triangular, or anyother shape and may even vary along its length.

The tip of prong may be blunt, for example, as shown in FIGS. 1 and 2,pointed (FIG. 11) and/or provided with barbs 84 for better anchoring intissue (FIG. 9). FIGS. 11 and 12 show a fastener 130 in accordance withanother embodiment of the fastener of the invention. The fastener 130 isshown in FIG. 11 in its undeployed configuration from a side perspectiveview. The fastener 130 is shown in FIG. 12 in its deployed configurationin a cross sectional view. The fastener 130 has a first element in theform of a crown 131 having a folded up lip 133. The fastener 130 alsohas a second element in the form of a baseplate 132 having a folded uplip 134. Prongs 135 extend from the crown 131 at hinge regions 136. Thebaseplate 132 has a number of slots 137 through which the prongs 135pass.

The fastener 130 is locked in the deployed configuration by snapping ofthe crown 131 beneath the lip 134 of the baseplate 132, as shown in FIG.12.

FIGS. 13 and 14 show a fastener 140 in accordance with anotherembodiment of the fastener of the invention. The fastener 140 is shownin FIG. 13 in its undeployed configuration from a side perspective view.The fastener 140 is shown in FIG. 14 in its deployed configuration froma bottom perspective view.

The fastener 140 has a circular crown 141 having a folded down lip 145along its edge, but does not have a baseplate. Prongs 143 extend fromthe crown 141 at hinge regions 146. Radial slots 147 in the lip 145 ofthe crown 141 are trapezoidal in shape being wider nearer to the edge ofthe lip 145. During deployment, the prongs 143, rotate outwardly aboutthe hinge regions 146, and become jammed in the narrower section of theradial slots 147, so as to lock the fastener 140 in its deployedconfiguration.

FIG. 15 shows a fastener 410 in accordance with another embodiment ofthe fastener of the invention. The fastener 410 has a first element 412in the form of a cylinder, to which prongs 413 are attached by hinges414. The first element 412 is situated within a second element 411 inthe form of a coaxial external cylindrical sleeve 411. The prong tips416 pass through slots 415 in the wall on the external sleeve 411. Anaxial movement of the inner sleeve 412 relative to the external sleeve411 in the direction of the arrow 417 exerts a force on the prongs andcauses them to rotate at the hinges 414 and extend radially outwardly,to penetrate surrounding structures or tissues.

FIG. 16a and FIG. 16b show another embodiment 720 in which the first andsecond elements are in the form of an inner sleeve 723 and an outersleeve 721, respectively. The outer sleeve is also provided with one ormore rows of prongs 722. FIG. 16a shows the fastener in the undeployedstate and FIG. 16b shows the fastener in the deployed state. The prongs722 of the outer sleeve 721 are oriented in proximity to slots 724 ofthe inner sleeve. When sliding the inner sleeve 723 axially, relative tothe outer sleeve, in the direction of the arrow 700 the slots 724 of theinner sleeve 724 exert a force on the prongs of the outer sleeve,forcing them to extend outwardly and acquire the deployed state (FIG.16b ). However, since the force exerted on the prongs 725 of the innersleeve 723 is in the opposite direction to the force exerted on theprongs 722 of the outer sleeve, the prongs of the outer sleeve and thoseof the inner sleeve extend with oppositely directed curvature. Thisprovides better gripping of the surrounding structures and/or tissues.Locking of the fastener in the deployed state may be by the engagementof the prongs with the slots' edges or by any other of the locking meanspreviously mentioned.

FIGS. 17 and 18 show a surgical fastener 180 in accordance with yetanother embodiment of the invention. The fastener 180 is shown in itsundeployed configuration in FIG. 17 and in its deployed configuration inFIG. 18. The fastener 180 has a first element 181 in the form of a diskfrom which extend prongs 186. The second element is in the form of anouter sleeve 187 provided with slots 185, through which prong tips 184,pass in the undeployed state. The fastener 180 is deployed by rotatingthe first element 181 inside the second element 187. As the firstelement 181 is rotated, the slot edges exert a force on the prongs andcause them to splay radially outward through the slots 185 so as topenetrate the surrounding structures and/or tissues.

Locking of the fastener of FIGS. 17 and 18 in the deployed configurationresults from the fact that the force applied on the prongs in order todetach the fastener from the tissue is perpendicular to force necessaryto bend the prongs to it's deployed configuration. Therefore, a momentdirected to detach the fastener will not be applied at the hinges in thesame way as the deployment moment, but at a much stronger region of theprongs resulting in locking the fastener in the deployed configuration.In this case the fastener may also be provided with one or more rows ofprongs. The fastener may be attached to a thread or filament and mayserve as an anchor.

FIGS. 19 and 20 a-20 c show a surgical fastening device 200 inaccordance with one embodiment of this aspect of the invention. Thefastening device 200 is shown in FIG. 19 in perspective view and inFIGS. 20a-20c in longitudinal section.

The fastening device 200 is used to deploy a surgical fastener 204 ofthe invention having a crown 214 and baseplate 215, such as the fastener100 shown in FIGS. 3 and 4. The fastening device 200 is provided with aslender shaft 207 having a proximal end 208 and a distal end 209. Theshaft 207 has a cylindrical sleeve 201 and a plunger 205. The distal endof the sleeve is provided with one or more stops 202 projecting radiallyinwards toward the longitudinal axis of the sleeve. Each stop 202 islocated at the end of a projection 212 cut in the wall of the sleeve201. As shown in FIGS. 19 and 20 a, the sleeve houses a single fastener204 in its undeployed configuration at the distal end of the sleeve 201between the stops 202 and a ramming head 211 located at the distal endof the plunger 205.

As shown in FIG. 20b , the distal end 209 of the fastener 200 isdelivered to a surface 216 of a tissue 213 where the fastener 204 is tobe deployed. The fastener 204 is then deployed by depressing the plunger205 distally within the sleeve 201. This is facilitated by pressing aknob 203 a located on the proximal end of the plunger 205 against aflange 203 b on the proximal end of the sleeve 201. As the ramming head211 presses on the crown 214 of the fastener 204, the stops 202 providea counter-pressure on the baseplate 215 so as to create axialcompression of the fastener 204, causing the prongs 217 of the fastenerto splay radially outward into the tissue 213 as the fastener 204attains its deployed configuration. The prong tips develop a curvedtrajectory as they penetrate into the tissue to a specific predetermineddepth and then move laterally, similar to the trajectory of a curvedsuturing needle within a tissue. The force necessary to fully spread theprongs 217 and deploy the fastener 204 is developed within the fasteningdevice 200 between the ramming head 211 and the stops 202 and is notapplied to the tissue, thus preventing damage to the tissue such astearing or perforating. The prongs of the fastener penetrate the tissuesmoothly and attach the fastener to the tissue. As shown in FIG. 20c ,after deployment of the fastener 204, the fastener 204 is released fromthe fastening device 200 by transiently displacing the stops 202radially outward. For example, the stops 202 may move radially outwardand release the fastener when a force is applied to the crown 214 by theramming head 211 that forces the baseplate 215 to pass the stops 202, byovercoming the elasticity of the projections 212. The force forreleasing the fastener is greater than the force required for bringingthe fastener to its deployed configuration. After the baseplate 215 haspassed the stops 202, the stops 202 return to their initial locationunder the influence of the elasticity of the projections 212. Afterdeployment, the crown 214 and the baseplate 215 of the fastener 204 areattached to the surface 216 of the tissue 213, and do not penetrate intothe tissue. The fastening device 200 can then be removed from the body.

FIGS. 21a-21c shows a second embodiment 220 of the fastening device ofthe invention. The fastening device 220 has several elements in commonwith the fastening device 200 described above in reference to FIGS. 19and 20 a-20 c, and these elements are indicated by the same referencenumerals in FIGS. 21a-21c as was used in FIGS. 19 and 20 a-20 withoutfurther comment. The shaft of the fastening device 220 includes anexternal sheath 222 that is coaxial with the sleeve 201. As shown inFIG. 21a , during deployment of the fastener 204, the external sheath222 is in a first position relative to the sleeve 201 in which itsurrounds the distal end of the sleeve 201, so that the stops 202 areprevented from moving radially outward during deployment of the fastener204. As shown in FIG. 21b , after deployment of the fastener, the sheath222 is retracted in a proximal direction by pulling on a knob 224 toexpose the distal end of the sleeve 201. The stops 202 are no longerconstrained in this position and move radially outward and thus releasethe fastener 204. The outward movement of the stops 202 may be, forexample, under the influence of the elasticity of the projections 212 orby being pushed out by the ramming head 211 as explained above inreference to FIGS. 19 and 20 a-20 c. Alternatively, the projections 212may be floppy.

FIGS. 22 and 23 show a second embodiment 230 of the fastening device ofthe invention. The fastening device 230 has several elements in commonwith the fastening device 220 described above in reference to FIGS. 21a-21 c, and these elements are indicated by the same reference numeralsin FIGS. 22 and 23 as was used in FIGS. 21a-21c without further comment.In the fastening device 230, the sheath 222 and the sleeve 201 areengaged by a connecting spring 233 that is pre-compressed to withstand aforce greater than the force necessary to compress the fastener into itsdeployed configuration. After compressing the fastener to its deployedconfiguration, a force that exceeds the pre-compressed force of thespring 233 is applied to the sleeve 201 so as to further compress thespring 233.

The sleeve 201 advances and extends beyond the distal end of the sheath222, and the stops 202 move outward, no longer being constrained by thesheath 222, thus releasing the deployed fastener 204. In order toprevent inadvertent actuation of the fastening device, a safety pin 235may be provided that has to be removed before use.

Another embodiment 250 of the fastening device of the invention shown inFIGS. 24, 25 and 26, has a curved sheath 251 surrounded by a tube 259.Longitudinal projections 252 extend from an annular ring 260. Eachprojection 252 engages, via a radial protrusion 253 extending from theprojection 252 towards a depression within the sheath 251. A tube 261 isattached to the inner surface of the surrounding tube 259. A plunger 258has a first segment 254 with a large diameter profile 254 and a moreproximally segment 255 having a narrower profile. The protrusions 253 ofthe projections 252 are forced outwardly within the depressions of thetube 261 by the distal larger diameter segment 254 of the plunger 258.During deployment of the fastener 264, the plunger 258 moves distallyrelative to the surrounding tube 259 and the tube 261, thus compressingthe fastener 264. As the plunger 258 advances distally the narrowerprofile 255 of the plunger 258 becomes situated in proximity to theprotrusions 253, as shown in FIG. 25. The constraint previously imposedon the protrusions 253 by the wide segment 254 of the plunger 258 isthus relieved, and the protrusions 253 can then move medially and leavethe tube 261. Depressing the plunger 258 further advances the plungerwithin the sheath and transmits a force to a complex consisting of theannular ring 260, the longitudinal projections 252, the protrusions 253and the stops 257. The force applied to the stops allows advancement ofthe complex in relation to the sheath tips 271. The unconstrained stops257 then release the fastener 264, as explained above.

FIG. 27 shows that a fastening device 381 of the invention may beattached to a handle 382 at an adjustable hinge 383, permittingdeploying a fastener at any desired angle. The fastening device 381 maybe any fastening device in accordance with the invention.

FIG. 28 shows another embodiment 745 of the surgical fastening device ofthe invention. The fastening device 745 has a bent shaft 742 thatextends from a handle portion 743. The shaft 742 can be rotated in thehandle portion 743 in order to direct the distal end 744 of the shaft inany desired direction. The shaft 742 is preferably detachable from thehandle portion 743.

The sheath of the shaft 742 may be provided at its distal end with axialprotrusions 741 that are used to grasp a mesh material in order to bringit to a desired position on a tissue surface when the mesh is to beattached by a fastener of the invention. The protrusions 741 may betriangular in shape, pear shaped, rod-like, or any elongated shape.

FIGS. 29a-29c shows an alternative structure for the distal end of ashaft 740 of the fastening device of the invention. This structure isused for deploying a surgical fastener 732 of the invention not having abaseplate, for example the fastener 70 shown in FIG. 8. A sheath 734 has“L” shaped projections 736 cut into its distal end separating slots 737.A sleeve 735 has straight projections 738 cut into its distal endseparating straight slots 7412. In this structure, the sheath 734 andthe sleeve 735 rotate in relation to one another. In one relativeposition of the sheath 734 and sleeve 735, blind slots 7411 are formedin the shaft 740 on the lateral side of the distal end of shaft as shownin FIG. 29 a.

Prongs 731 of the fastener 739 are forced through the blind slots 7411when a plunger 733 is moved distally inside the sleeve 735 to push thecrown 732 (not visible in FIGS. 29a and b ) distally inside the sleeve735. As the crown 732 moves distally in the sleeve 735, the prongs 731splay out (FIG. 29b ) as the fastener 739 attains its deployedconfiguration. In order to release the fastener 739 from the fasteningdevice, the sheath 734 is rotated about the sleeve 735 to generate openslots 737 at the distal end of the shaft 740 through which the prongscan pass, as shown in FIG. 29c . The fastening device can then beremoved from the body.

FIG. 30 shows an alternative structure for the distal end of a shaft 280of the fastening device of the invention. This structure is used fordeploying a surgical fastener 281 of the invention not having abaseplate, for example the fastener 70 shown in FIG. 8. The fastener 281is positioned at the distal end of a sleeve 282 with prongs 283 facingproximally. A crown 284 of the fastener 281 has a central hole 285 towhich is attached a knob 286, on its distal aspect. The holding means isattached to an axial filament or rod 287 longitudinally traversing thesleeve to the proximal end and serves for pulling the fastener againstthe distal edge 287 of the sleeve 282. As the filament or rod 287 ispulled proximally, a force is applied to the prongs 283 by the edge 287of the distal end of the sleeve 282 causing the prongs to rotate athinge regions 288 and to splay radially outward and penetrate a coveringor mesh and/or tissue, as the fastener 281 attains its deployedconfiguration. After deployment, the knob 286 and filament or rod 287may be left within the body or the filament or rod 287 may be cut.

FIG. 31 shows an alternative structure for the distal end of a shaft ofthe fastening device of the invention. A sleeve 391 inside the shaft isadapted to receive and deploy two or more surgical fasteners of theinvention such as fasteners 29 a, 29 b, and 29 c. The fasteners arestacked one above another inside the sleeve 391, and a plunger (notshown in FIG. 31) is used to push upon the proximal-most fastener in adistal direction. The force is transmitted through the stack offasteners to the distal-most fastener 29 b. The fastening device may beprovided with a mechanism, such that when the penultimate fastener 29 apresses the distal-most fastener 29 b, the stack of fasteners movesdistally and the baseplate 395 of the penultimate fastener 29 a pushes Sshaped stops 393 radially outward to release the deployed fastener.

FIG. 32 shows the stack of fasteners alone. The fasteners 29 a and 29 bare provided with a mechanism to prevent premature outward extension ofthe prongs of all of the fasteners in the stack except for thedistal-most fastener 29 b during application of an axial force throughthe entire stack of fasteners by the plunger. Premature extension of theprongs may prevent passage of the stack of fasteners through the sleeveby jamming of the prongs into the sleeve wall. A baseplate 293 of eachfastener has slots 294 provided with a leaflet 295 that is connected tothe baseplate 293. A crown 291 of each fastener is provided with radialprojections 292. A space between the leaflet 295 and the edge of theslot 294 permits only the tip of the prongs to pass while obstructingthe passage of the shaft of the prongs through the slots 294 due to itslarger width. When an axial force is applied to the distal most fastener29 b, a force is applied between the tips 297 of the prongs and theleaflets 295, causing the leaflets 295 to rotate and extend downward,opening the space between the leaflets and the edge of the slots 294,and permitting the prongs to pass through the slots. However, the otherfasteners in the stack, such as the fastener 29 a, are oriented so thatthe crown projections 292 of the fastener 29 b are situated beneath theleaflets of the fastener 29 a. Thus, when an axial compression force isapplied through the fasteners other than the distal most fastener, theprojections of the crown of the underlying fastener support the leafletsof the slots of the overlying fastener and prevent them form projectingdownwardly and preventing the prongs from passing through the slots.

Another mechanism for preventing premature deployment of a fastener in astack of fasteners is to fill the baseplate slots with a plug of amaterial such as a biodegradable plastic material. The slots with theirplugs of a fastener are supported by the projection of the crown of theunderlying fastener, except for the slots of the distal most fastener.When a force is applied to the distal-most fastener by the plunger, theprongs are forced through the slots pushing out the plugs.

FIG. 33 shows yet another alternative structure for the distal end ofthe fastening device of the invention. In this structure, a sleeve 302is provided. A distal segment 303 of an outer sheath 301 constrainsstops 304 of the distal end of a sleeve 302 from moving radiallyoutward. A plunger (not shown in FIG. 33) is provided with a ratchetmechanism that permits only distally directed movement of the stack offasteners within the sleeve 302. One or more inner projections 305 arecut in the wall of the sleeve 302 at the distal end of the sleeve thatprevent ejection of the remaining fasteners 306 during release of thedistal-most fastener 307 in its deployed configuration. In this case,the distal-most fastener may be deployed and released using onecontinuous movement of a lever provided in the handle of the fasteningdevice.

FIGS. 34a-34e shows a deployment mechanism for a fastening device of theinvention. A handle has a housing in which a plunger 311, sleeve 313 andsheath 312 are coupled through springs of predetermined length andstrength. By compressing a lever (not shown in FIGS. 34a-34e ), theplunger 311 is advanced distally compressing the distal-most fastenerthrough the stack of fasteners. An encasement 314 attached to theplunger 311 is urged against the encasement 315 attached to the sleeve313 closing a space 316 a to bring the device to the configuration shownin FIG. 34b . The sleeve encasement 315 is thus engaged and is caused tomove distally relative to the sheath encasement 318, closing a space 317a between them to bring the device to the configuration shown in FIG.34c but without releasing stops (such as the stops 304 in FIG. 33) thathold the distal most fastener. This movement constrains an innerblocking protrusion (such as the protrusions 305 shown in FIG. 33) tomove medially. Continuing to press the lever further advances theplunger 311 within the sleeve 313 and further compress the distal-mostfastener against the stops as it acquires its deployed configurationwith the prongs fully splayed while preventing the other fasteners frombeing deployed due to the blocking protrusion. This advancement of theplunger within the sleeve brings the device to the configuration shownin FIG. 34d by the advancement of the plunger encasement 314 in relationto the sleeve encasement 315 and opening a space 319. With continueddepression of the lever, the force exerted by the plunger exerts apressure on the distal-most fastener, while releasing the constraint onthe distal stops so as to eject the distal-most fastener. This bringsthe device to the configuration illustrated in FIG. 34e in which theencasement of the plunger 314 has advanced inside the encasement of thesleeve 315, increasing the space 319.

FIG. 35 shows another deployment mechanism for deploying a fastener ofthe invention. A first lever 321 is used to deploy the distal-mostfastener in a stack of fasteners and a second lever 322 is used torelease the fastener from the fastening device. The lever 321 acts on aplunger 323 through a ratchet mechanism 324 and applies a force to adistal-most fastener to achieve compression of the distal-most fasteneragainst stops and to bring the distal-most fastener to its deployedconfiguration. The lever 322 is connected to the proximal end of anouter sheath 329 that can move proximally relative to the sleeveresulting in release of the deployed fastener.

A thread or filament 326 that passes through the stack of fasteners isgrasped between the crown and baseplate of the deployed fastener. Thethread 326 is wound on a drum 327 that may be locked or released by anactuating knob 328.

When too much thread has been released, the drum 327 can be rotated by aknob 325, rewinding the excess thread. FIG. 31 shows the distal end ofthe shaft with a filament passing through the stack of fasteners.

FIGS. 36, 37, and 38 show another embodiment of the fastening device ofthe invention. A compressed spring 341, serves to advance a stack offasteners distally. A sleeve 342 is provided with stops 344 at itsdistal end that prevent ejection of fasteners other than the distal-mostfastener and stops 345 that prevent the distal-most fastener 348 frommoving proximally inside the shaft. The distal-most fastener 348 isgrasped by stops 346 of a sheath 343 and compressed against stops 347 ofthe sleeve. Retracting a sheath 343 removes the constraint on the stops347 and permits the release of the deployed distal-most fastener 348.

FIG. 39 shows another possible structure of the shaft having a ratchetmechanism to promote movement of the fasteners in the shaft Innerprojections 363 and 365 from a sleeve 361 and inner projections 364,from an outer sheath 362 permit only distal movement of the fastenersshown in FIG. 40, with every reciprocating movement of the sheath 362 inthe sleeve. The distal-most of these projections 366 from the sheath 362serves as a plunger and thus serves to compress the distal-most fasteneragainst stops 367.

1. A surgical fastener having an undeployed configuration and a deployedconfiguration, the surgical fastener comprising: (a) a first elementdefining an axis of the fastener; and (b) two or more prongs, each ofthe two or more prongs being attached to the first element at a hingeand each of the two or more prongs having a tip; wherein, in theundeployed configuration, the tip of each of the two or more prongs isat a first distance from the axis that is greater than a distance of theprong's hinge from the axis; and wherein, in the deployed configuration,the tip of each of the two or more prongs is at a second distance fromthe axis that is greater than the first distance and wherein thefastener is locked in the deployed configuration.
 2. The surgicalfastener according to claim 1, further comprising a second elementhaving slots, a tip of one or the two or more prongs being engaged inone of the slots in the undeployed configuration.
 3. The surgicalfastener according to claim 2, wherein the surgical fastener is lockedin the deployed configuration by an engagement between the first elementand the second element.
 4. The surgical fastener according to claim 1,wherein the surgical fastener is locked in the deployed configuration byan engagement between the first element and the prongs.
 5. The surgicalfastener according to claim 1, wherein the hinge between the firstelement and the two or more prongs is a two part hinge.
 6. The surgicalfastener according to claim 2, wherein the second element is an externalsleeve surrounding the first element, and the second element is providedwith openings that engage the two or more prongs of the surgicalfastener and that achieve the deployed configuration by rotating thefirst element relative to the second element.
 7. The surgical fasteneraccording to claim 2, wherein the first element is includes a first holeand the second element includes a second hole.
 8. The surgical fasteneraccording to claim 7, wherein the first hole and the second hole are notcoaxial.
 9. A surgical fastening device for deploying one or moresurgical fasteners, each of the one or more surgical fasteners having anundeployed configuration and a deployed configuration, each of the oneor more surgical fasteners comprising: (a) a first element defining anaxis of the fastener; and (b) two or more prongs, each prong beingattached to the first element at a hinge and each prong having a tip;wherein, in the undeployed configuration, the tip of each of the two ormore prongs is at a first distance from the axis that is greater than adistance of the prong's hinge from the axis; and wherein, in thedeployed configuration, the tip of each of the two or more prongs is ata second distance from the axis that is greater than the first distance;the surgical fastening device comprising: a. a receptacle adapted toreceive the one or more surgical fasteners in the undeployedconfiguration; and b. a deployment mechanism configured to bring one ofthe one or more surgical fasteners in the receptacle to its deployedconfiguration by applying a first force to the first element and asecond force to the two or more prongs, wherein the second force isdirected in a direction generally opposite to the direction of the firstforce.
 10. The surgical fastening device according to claim 9, whereinthe receptacle is a sleeve configured to receive a stack of one or moreof the surgical fasteners, the sleeve having a proximal end and a distalend.
 11. The surgical fastener according to claim 10, configured todeploy one of the one or more surgical fasteners with the surgicalfastener oriented with its prongs directed in a distal direction. 12.The surgical fastener according to claim 10, configured to deploy one ofthe one or more surgical fasteners with the surgical fastener orientedwith its prongs directed in a proximal direction.
 13. The surgicalfastening device according to claim 10, further comprising a plungerhaving a ramming head located in the sleeve configured to deliver adistally directed force on the proximal-most fastener in the stack. 14.The surgical fastening device according to claim 10, further comprisingstops at the distal end of the sleeve, the stops having a first positionin which they prevent release of the distal-most fastener in the sleeve.15. The surgical fastening device according to claim 10, furthercomprising a releasing mechanism configured to release the distal-mostfastener after having been deployed, the releasing mechanism configuredto move the stops to a second position in which the stops do not preventrelease of the distal-most fastener in the sleeve.
 16. The surgicalfastening device according to claim 15, wherein the releasing mechanismconfigured to move the stops to a second position in which the stops donot prevent release of the distal-most fastener in the sleeve.
 17. Thesurgical fastening device according to claim 13, wherein the fastenersare advanced in the sleeve by a ratchet mechanism.
 18. The surgicalfastening device according to claim 13, in which the fasteners areadvanced by a spring.
 19. The surgical fastening device according toclaim 13, wherein a stack of the one or more surgical fasteners in thereceptacle moves distally when the ramming head delivers a distallydirected force on the proximal-most fastener in the stack.
 20. Thesurgical fastening device according claim 10, further comprisingprojections at the distal end configured to grasp a surgical mesh. 21.The surgical fastening device according to claim 10, further comprisinga surgical filament delivery system delivering a surgical filament thatis grasped by a deployed fastener.
 22. The surgical fastening deviceaccording to claim 21, further comprising a mechanism to control thelength and tension of the filament between fasteners.
 23. A surgicalfastening system, comprising: (a) a surgical fastening device fordeploying one or more surgical fasteners, each of the one or moresurgical fasteners having an undeployed configuration and a deployedconfiguration, each of the one or more surgical fasteners comprising:(i) a first element defining an axis of the fastener; and (ii) two ormore prongs, each of the two or more prongs being attached to the firstelement at a hinge and each prong having a tip; wherein, in theundeployed configuration, the tip of each of the two or more prongs isat a first distance from the axis that is greater than a distance of theprong's hinge from the axis; and wherein, in the deployed configuration,the tip of each of the two or more prongs is at a second distance fromthe axis that is greater than the first distance; the surgical fasteningdevice comprising: a receptacle adapted to receive the one or moresurgical fasteners in the undeployed configuration, a deploymentmechanism configured to bring a fastener in the receptacle to itsdeployed configuration by applying a first force to first element and asecond force to the prongs wherein the second force is directed in adirection generally opposite to the direction of the first force; and areleasing mechanism for disengaging the fastening device from the fullydeployed fastener; and (b) one or more surgical fasteners, each of theone or more surgical fasteners comprising: (i) a first element definingan axis of the fastener; and (ii) two or more prongs, each prong beingattached to the first element at a hinge and each prong having a tip;wherein, in the undeployed configuration, the tip of each prong is at afirst distance from the axis that is greater than a distance of theprong's hinge from the axis; and wherein, in the deployed configuration,the tip of each prong is at a second distance from the axis that isgreater than the first distance.
 24. A method for attaching a surgicalfastener to a site of a body tissue, the surgical fastener comprising:(a) a first element defining an axis of the surgical fastener; and (b)two or more prongs, each of the two or more prongs being attached to thefirst element at a hinge and each of the two or more prongs having atip; wherein, in the undeployed configuration, the tip of each of thetwo or more prongs is at a first distance from the axis that is greaterthan a distance of the prong's hinge from the axis; and wherein, in thedeployed configuration, the tip of each of the two or more prongs is ata second distance from the axis that is greater than the first distance;the method comprising: applying an extending force to the two or moreprongs to fully deploy the surgical fastener by forces exercised withinthe fastening instrument, wherein the extending prongs pierce a mesh ora graft and the adjacent tissue and the first element of the surgicalfastener attach said mesh or graft to the tissue.